21 November 2016 - Investigational new drug application for use of H.P Acthar Gel in amyotropic lateral sclerosis awarded fast track designation by U.S. FDA.
Mallinckrodt today confirmed that it will initiate a company-sponsored, Phase 2 proof-of-concept clinical trial to assess the efficacy of H.P. Acthar Gel (repository corticotropin injection) in patients with amyotropic lateral sclerosis, also known as Lou Gehrig's disease.
The trial is expected to begin in the first half of 2017.